U.S. patent number 9,687,621 [Application Number 13/829,509] was granted by the patent office on 2017-06-27 for dual lumen endobronchial tube device.
This patent grant is currently assigned to The Regents of the University of California. The grantee listed for this patent is Mike Hoftman, Nir Hoftman, Aman Mahajan. Invention is credited to Mike Hoftman, Nir Hoftman, Aman Mahajan.
United States Patent |
9,687,621 |
Hoftman , et al. |
June 27, 2017 |
Dual lumen endobronchial tube device
Abstract
The present invention is a dual lumen endobronchial tube
provided with a flexible wall dividing a cylindrical main tube into
two lumens, where the outside wall of the main tube is reinforced,
preferably by metal wire but alternately by a sufficiently rigid
polymer ribbing which will achieve a desired reduction necessary
outside wall thickness. The achievement of a reduction in necessary
wall thickness enables sufficient hydraulic cross sectional area so
that each lumen is capable independently of providing adequate
ventilation to a patient even while a ventilation lumen is partly
occluded when the insertion end of a bronchoscope or tube is
inserted into the adjacent lumen to examine or treat the other
lung.
Inventors: |
Hoftman; Nir (Los Angeles,
CA), Mahajan; Aman (Sherman Oaks, CA), Hoftman; Mike
(Chatsworth, CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Hoftman; Nir
Mahajan; Aman
Hoftman; Mike |
Los Angeles
Sherman Oaks
Chatsworth |
CA
CA
CA |
US
US
US |
|
|
Assignee: |
The Regents of the University of
California (Oakland, CA)
|
Family
ID: |
51625188 |
Appl.
No.: |
13/829,509 |
Filed: |
March 14, 2013 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20170072154 A1 |
Mar 16, 2017 |
|
Related U.S. Patent Documents
|
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
61690867 |
Jul 6, 2012 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M
16/0404 (20140204); A61M 16/0434 (20130101); A61M
16/0486 (20140204); A61M 16/0459 (20140204); A61M
16/0816 (20130101); A61M 16/0445 (20140204); A61M
2016/0033 (20130101); A61M 16/0488 (20130101); A61M
2016/0027 (20130101); A61M 16/0463 (20130101) |
Current International
Class: |
A61M
16/04 (20060101); A61M 16/08 (20060101); A61M
16/00 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Ho; Tan-Uyen (Jackie) T
Assistant Examiner: Boecker; Joseph D
Attorney, Agent or Firm: Riverside Law LLP
Parent Case Text
This application claims the benefit of a provisional application
with Ser. No. 61/690,867 filed Jul. 6, 2012, which application is
hereby incorporated herein by reference and from which priority is
hereby claimed under 35 U.S.C. Sections 119(e) and 120.
Claims
We claim:
1. An endotracheal tube with a main tracheal tube that defines a
longitudinal cylindrical internal space that is divided lengthwise
by a dividing wall to define two internal and adjacent tracheal
lumens within the main tracheal tube, the endotracheal tube being
adapted for a tracheal cuff sealing by way of a tracheal cuff of a
patient's trachea, the tracheal cuff being supported from the main
tracheal tube and being further adapted for a bronchial cuff
sealing by way of a bronchial cuff of a bronchus of the patient,
the bronchial cuff being supported from a bronchial tube that
extends downward from the main tracheal tube and which defines an
internal bronchial tube lumen extending one of the tracheal lumens
comprising: a) the dividing wall forms two sealing attachment lines
lengthwise down an inside surface of the main tracheal tube,
whereby the two sealing attachment lines are offset from a midline
of the tracheal tube such that the dividing wall extends away from
the inside surface at points that are offset from the midline of
the tracheal tube, wherein the cross section areas of the two
internal and adjacent tracheal lumens are about equal when the
dividing wall is at rest; b) at a lower end of the main tracheal
tube, the tracheal cuff is located above a first opening of the
main tracheal tube defined at a distal end of the tracheal lumen
that does not extend to the bronchial tube lumen; and c) the
bronchial tube lumen terminates at a distal bronchial opening and
the bronchial cuff is located above the distal bronchial
opening.
2. The endotracheal tube of claim 1 wherein the thickness of the
dividing wall is from 2.5 to 0.5 millimeters.
3. The tube of claim 1 wherein the dividing wall is smooth and
semilunar at rest.
4. The endotracheal tube of claim 1 wherein the dividing wall is
segmented in an accordion shape but is generally in a flattened
orientation.
5. The endotracheal tube of claim 1 wherein the dividing wall is
segmented in an accordion shape but is generally in a semilunar
orientation.
6. A specialty endotracheal tube comprising: a) a tracheal tube and
a bronchial tube, the bronchial tube extending from a distal end of
the tracheal tube; b) a tracheal tube lumen defined by inside walls
of the tracheal tube; c) a dividing wall longitudinally dividing
the tracheal tube lumen and, with the inside walls of the tracheal
tube, defines a short lumen and a long lumen adjacent to each other
in the tracheal tube; d) the short lumen comprising a first upper
opening and a first lower opening near a connection of the
bronchial tube to the distal end of the tracheal tube; e) the long
lumen comprising a second upper opening and a second lower opening
into a bronchial lumen defined by inside walls of the bronchial
tube; f) the bronchial tube lumen comprising a third lower opening;
g) a first inflatable cuff fixed above the first lower opening of
the short lumen on an outside wall of the tracheal tube; h) a
second inflatable cuff fixed above the third lower opening of the
bronchial lumen on an outside surface of the bronchial tube; and i)
two sealing attachments of the dividing wall along the inside walls
of the tracheal tube are offset from a midline of the tracheal tube
such that the dividing wall extends away from the inside walls at
points that are offset from the midline of the tracheal tube,
defining cross sectional areas of the short lumen and long lumen
that are about equal when the dividing wall is at rest.
7. The specialty endotracheal tube of claim 6 wherein the dividing
wall is semilunar in cross section shape at rest.
8. The specialty endotracheal tube of claim 6 wherein the dividing
wall comprises, in cross section, a convex surface opposite an
inside wall of the tracheal tube of the long lumen.
9. The specialty endotracheal tube of claim 8 wherein the dividing
wall is flexible such that insertion of a medical device into the
long lumen, due to an offset sealing attachment of the dividing
wall, prevents the short lumen from becoming occluded for
ventilation of a patient.
10. The specialty endotracheal tube of claim 6 wherein the dividing
wall comprises, in cross section, a concave surface opposite an
inside wall of the tracheal tube of the short lumen.
11. The specialty endotracheal tube of claim 10 wherein the
dividing wall is flexible such that insertion of a medical device
into the short lumen, due to an offset sealing attachment of the
dividing wall, prevents the long lumen from becoming occluded for
ventilation of a patient.
12. The specialty endotracheal tube of claim 6 wherein the dividing
wall comprises, in cross section, a convex surface opposite an
inside wall of the tracheal tube of the short lumen.
13. The specialty endotracheal tube of claim 12 wherein the
dividing wall is flexible such that insertion of a medical device
into the long lumen, due to an offset sealing attachment of the
dividing wall, prevents the long lumen from becoming occluded for
ventilation of a patient.
14. The specialty endotracheal tube of claim 13 wherein the
dividing wall comprises, in cross section, a concave surface
opposite an inside wall of the tracheal tube of the long lumen.
15. The specialty endotracheal tube of claim 6 wherein an inside
diameter of the tracheal tube is 10 millimeters and an outside
diameter is 13 millimeters.
16. An endotracheal tube comprising: a tube having an inner wall
and a membrane attached to the inner wall defining a first lumen
and a second lumen within the tube, wherein the membrane extends
away from the inner wall at points that are offset from a midline
of the tube; wherein, when the membrane is at rest, the cross
sectional areas of the first and second lumens are about equal, and
wherein, when an instrument is inserted into the first lumen, the
membrane is suitably flexible to increase the cross sectional area
of the first lumen while maintaining in the second lumen a reduced
cross sectional area suitable for ventilation through the second
lumen.
Description
FIELD OF THE INVENTION
The present invention relates to devices which provide lung
isolation and one lung ventilation, and providing bronchoscope
access to one side of the lungs while simultaneously providing
respiration flow to the other side of the lung.
BACKGROUND OF THE INVENTION
Endotracheal tubes are used to couple a patient's respiratory
system to a breathing apparatus during surgical procedures or
emergency situations. A typical endotracheal tube is made of PVC
(polyvinyl chloride), silicone, or similar material and has an
inflatable cuff positioned a distance centimeters from an end of
the tube that is inserted into the trachea. Thus, the tube can be
sealed relative to the trachea by inflating the cuff through an
inflation line extending along the endotracheal tube. A fitting on
an opposite end of the tube couples the endotracheal tube to an
artificial respirator or ventilator.
As is also well known to those skilled in the medical arts, a
double lumen endotracheal tube is required in many kinds of
thoracic, spine, lung or major vascular surgery when it is
necessary to perform single lung ventilation or to ventilate both
the left and right lungs separately. A conventional double lumen
endotracheal tube provides for individualized ventilation of the
two lungs with two lumens each having a cuff positioned about a
circumference at proximal (tracheal) and distal (bronchial)
locations. The bronchial lumen may extend into either the right or
left main bronchus while the tracheal lumen remains in the trachea.
The prior art double lumen endotracheal tube is limited by its
large diameter which can unfortunately lead to bronchial damage and
even vocal cord scarring, especially when it is left in place for a
long period of time. Thus, when post-operative ventilation support
is anticipated for a patient, the double lumen endotracheal tube is
usually removed at the end of the operation and is replaced with a
conventional single lumen tube. However, the conventional double
lumen endotracheal tube can be associated with significant upper
airway swelling due to massive fluid resuscitation during the
course of a surgical operation. Under these circumstances,
replacement of the double lumen endotracheal tube with a single
lumen tube in order to attempt to minimize the aforementioned
bronchial damage and vocal chord scarring can be a potentially
hazardous and occasionally life-threatening procedure. This is due
to the fact that it can be very difficult for an anesthesiologist
to see the upper airway and vocal chords adequately to replace the
single lumen tube in the swollen upper airway.
Further, it is well known that sudden expiration, such as coughs or
spasms, during intubation can cause the bronchi to contract as much
as 40 percent in diameter, resulting in substantial compression
circumferentially about the bronchial cuff. The prior art cuffs
respond appropriately for a smooth, blimp-shaped balloon. The mucus
covering of the bronchus and the reaction of its muscles are
adapted to expel something the size of the bronchial cuff, which is
forced upward, sometimes with sufficient force to cause a bronchial
lumen to buckle to force the entire tracheal tube upwards. In such
circumstances, the bronchial lumen can be moved into a position so
that its terminal opening is moved from the desired bronchus to an
undesired location in the trachea or even the other bronchus.
The prior art dual lumen tubes have the following disadvantages
when used for one-lung respiration combined with a desired
bronchoscope examination of either of the two lungs. (a) Insertion
and location of cuffs requires a high degree of skill.
(b) Without being able to see the cuff locations after intubation,
it is difficult to keep the bronchial lumen tube fixed at a desired
position and the tube often enters deep into or comes out of
position during anesthesia.
Prior art non-bronchoscopic dual lumen tubes are shown in U.S. Pat.
Nos. 4,453,545 and 4,233,984, where the sole intent of the dual
lumen structure is to accomplish selective ventilation of the
lungs. Neither of these are adaptable to use with a bronchoscope
inserted into one of the lumens. The '948 patent device provides a
lumen separation which is intended to respond with side to side
collapse with a very minor pressure difference. The '545 patent
describes that the FIG. 2 device is simply not stable and teaches
away from its use in favor of a relatively small diameter bronchial
lumen tube with an enlarged cuff. The enlarged cuff lacks
position-maintaining tube support which might preserve its location
in the lung.
Referring again to surgical environments where dual lumen tube
respiration is desired, it is well known that surgery involving the
lung or the contents of the thorax often requires cessation of
ventilation to one lung to keep the lung immobile while surgery on
it is performed or to deflate the lung for better visualization of
thoracic structures. Other indications for lung isolation include:
containment of unilateral pulmonary bleeding or infection and
management of bronchopleural fistula or other pulmonary air leaks.
The generally accepted prior art solution for lung isolation is the
double lumen endotracheal tube. Modern disposable plastic double
lumen tubes are modifications of the original Robert-Shaw tube
introduced more than sixty years ago. These endotracheal tubes
contain two separate lumens, one for each lung, and ventilation is
separated with the use of endotracheal and endobronchial balloon
cuffs. The DLT design suffers from two major drawbacks that
negatively affect clinical care. The first is the large size of the
tube, namely its effective diameter and cross-sectional surface
area. Current adult sized double lumen tubes are typically 35-41
French in external circumference; this large size is needed to
accommodate the necessary plastic structure (extruded walls) and
ventilation passages. Aside from being large, the double lumen
tubes are also relatively stiff due to the plastic material used in
their construction. The combination of their large and bulky design
and undesired stiffness can lead to difficult insertion and even
airway injury. Even if insertion is atraumatic, the double lumen
tubes' large external diameter increases the pressure on the
glottic opening, potentially injuring these delicate structures,
especially during prolonged intubations.
The second major design drawback to the prior art double lumen
tubes is the relatively small size of the ventilation passages.
Even the current prior art double lumen tubes have large external
diameters, resulting in a bulky design to house two relatively
small diameter channels, thus limiting the size of bronchoscopes,
suction catheters, and other instruments that could be inserted
into the lungs during use. No adult double lumen tube sizes (35-41
Fr) can accommodate a pulmonary bronchoscope needed to perform
diagnostic or therapeutic bronchoscopy (minimum 4.9 mm O.D.). If a
diagnostic or therapeutic bronchoscopy exam is to be performed
(suction/lavage, bronchial biopsy, bronchial laser) prior to
surgical lung resection, a standard large bore endotracheal tube
must first be utilized for this part of the procedure to
accommodate the large bore bronchoscope. Once the bronchoscopy is
completed, the endotracheal tube must be removed and a separate
double lumen tube must be inserted in its place, a procedure that
is often fraught with risk. A limited lumen diameter imposed on
double lumen tubes poses a special clinical challenge when a
patient is bleeding from one lung, and lung isolation is warranted.
Although a double lumen tube is ideal for lung isolation to prevent
flooding the good lung with blood, placement of a double lumen tube
severely limits one's ability to perform the diagnostic and
therapeutic bronchoscopy necessary to treat this medical
emergency.
SUMMARY OF THE INVENTION
The present invention is a dual lumen endotracheal tube provided
with a flexible wall dividing a cylindrical main tube into two
lumens, where the outside wall of the main tube is reinforced,
preferably by metal wire but alternately by a sufficiently rigid
polymer ribbing which will achieve a desired reduction necessary
outside wall thickness. The achievement of a reduction in necessary
wall thickness enables sufficient hydraulic cross sectional area so
that each lumen is capable independently of providing adequate
ventilation to a patient even while a ventilation lumen is partly
occluded when the insertion end of a bronchoscope or tube is
inserted into the adjacent lumen to examine or treat the other
lung.
The invention dual lumen tube makes critical changes to the
standard prior art, such as the 40 cm adult double lumen
endotracheal tube, which had the basic configuration of the
"Robert-Shaw" classic design. The invention device is composed of
two separate lumens, a bronchial and a tracheal, which terminate
distally and proximally, respectively. Also present in the
invention design are the bronchial and tracheal balloon cuffs,
which are utilized to achieve lung isolation. The invention device
further comprises, in contrast to the prior art large diameter,
thick walled and stiff endotracheal tube, a soft, thin walled
material (e.g. plastic, silicone or a similar polymer). The outer
wall of this tube is reinforced with an embedded steel coil, wire
or polymer ribbing to add structural rigidity to this thin-walled
structure. This allows the wall thickness to be reduced, as the
tube's rigidity is dependent primarily on the steel coil and not
the plastic component. Thinner walls translate to a reduction of
the total external diameter of the tube. This construction also
allows the invention device tube to be much less rigid, because a
reinforced tube can easily flex and bend without compromising the
axial rigidity needed to maintain luminal patency. The entire
endotracheal tube may in one form comprise a gentle curve as would
a standard single lumen endotracheal tube, rather than the multiple
curves and angulations of a typical "Robert-Shaw" design tube that
can hinder the laryngeal view during laryngoscopy. The combination
of 1) smaller size, 2) ergonomic single curve, and 3) more flexible
structure can make insertion both easier and less traumatic. Thus,
the invention design maximizes the lumen inside diameters while
minimizing the total outside diameter of the main tube, whereby
only two adult sizes may be needed to satisfy a wide range of
patient variability. Thus, rather than having size 35F, 37F, 39F,
and 41F, the invention design may be supplied "small adult" and
"large adult" sizes. There are benefits mentioned in the
provisional that may need to be included here such as: cost savings
to medical facilities to fewer inventory devices, simplification of
procedure and less chance for an error by the practitioner in
having only 2 sizes that are adequate for left and right lung
ventilation, etc.
Further, current prior art dual lumen endotracheal tube designs
require separate "right sided" and "left sided" configurations
depending on whether the bronchial portion of the tube is to be
placed in the right or left mainstem bronchus. The invention tube,
is preferably provided in one configuration. A user vertically
rotates the invention device 180 degrees to change the orientation
of the bronchial lumen from left to right. To use the invention
device as a left sided dual lumen endotracheal tube designs, a user
inserts the tube with the bronchial lumen pointing to the patient's
left, thus placing the bronchial lumen into the left mainstem
bronchus. To use the invention device as a right sided dual lumen
endotracheal tube designs, a user will reverse the just described
rotation.
To aid in correct insertion of the invention dual lumen
endotracheal tube designs, the invention may be used with a
specialized stylet to create the proper tube orientation and
curvature. The stylet is semi-rigid and malleable to aid in tube
insertion into the airway, but the stylet distal tip will be more
flexible. This design will allow the stylet to point the bronchial
lumen tube in the right direction (to a mainstem bronchus of one's
choosing) without posing an increased risk of airway rupture or
serious injury.
In another form it will be steerable and will integrate a video
chip camera to enable visualization of the airway. This will enable
the practitioner to obtain and maintain proper device positioning
within the airway.
In another form of the invention, the tracheal and/or bronchial
balloon cuffs are changed from the typical smooth blimp shaped
cuffs currently in use. The cuffs will change in: 1) shape and/or
2) surface texture. Rather than being blimp shaped, the balloon
cuffs would retain a more precise cylindrical configuration similar
to the surface area in contact with the airway would be maximized.
Their texture, rather than being smooth and slippery, may be
roughened such that a small amount of friction is formed between
the cuff and airway. These two attributes are likely to maximize
the air seal for ventilation, while minimizing the balloon pressure
needed to achieve this seal. Furthermore, the increased friction
would reduce the likelihood of tube dislodgement or movement during
clinical use.
The main tube of the invention device is a reinforced flexible
plastic tube and contains a flexible internal membrane throughout
its entire length that divides the space into two separate lumens.
Unlike the current dual lumen endotracheal tube designs, the
separation between the lumens is not achieved by a thick rigid
internal wall, but rather by a flexible intraluminal membrane. In
cross-section, the membrane configuration is semi-lunar, with the
convex curve facing the tracheal lumen. The attachment points of
this membrane to the inner wall of the tube are slightly offset
away form the midline in the direction of the bronchial lumen, so
that the cross-sectional areas of the two lumens are relatively
balanced. During both two and one-lung ventilation, this membrane
rests in its neutral position. However, the flexible nature of this
divider-membrane allows it to deform in order to accommodate larger
bronchoscopes. Thus, should a large bronchoscope need to be
inserted into the invention device, it would preferably be
introduced into the tracheal lumen. The intraluminal membrane would
then deform away from the bronchoscope, creating a larger lumen
that can accommodate this large instrument. The invention device
may be pulled back so that its distal bronchial tube tip is above
the carina if a full (two lung) bronchoscopy exam is to be
performed. This flexible intraluminal membrane design also allows
for other large caliber tubes to be inserted, such as large bore
suction catheters.
For the one form of operation of the invention device, a bronchial
lumen connector tube connects to the bronchial lumen through a
side-orifice in the main tube. This connector slides over the tube
external diameter via a ring, and the tubular orifice of the
connector lines up with the side-orifice of the bronchial lumen,
where it is permanently bonded. A specialized Y-piece may be
connected to the two connectors. This Y-piece serves the usual dual
function of 1) allowing for simultaneous ventilation of both lumens
with one ventilator, and 2) allowing for bronchoscopy to be
performed during positive pressure ventilation. However, this
Y-piece will have one unique feature not seen in current Y-piece
design, namely it will contain built in flow control clamps. Thus,
rather than having to attach a metal instrument clamp to close one
tube during one-lung ventilation (as is often performed), a Y-piece
clamp is simply closed. One-lung ventilation can now be performed
while still leaving the Y-piece in the circuit, without the need
for an external instrument clamp.
It is also an object of the invention to incorporate adjustable gas
flow clamps onto the Y connector tubes with an external attachable
gas flow sensor to monitor gas flow.
It is also an object of the invention to incorporate tube occluding
clamps onto the Y connector tubes to occlude one tube at a time if
desired.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a front, cross section view of a human lung, shown the
tracheal and bronchial structures relevant to the present
invention.
FIG. 2 is a front view of one form of the invention dual lumen
tube.
FIG. 3 is a perspective of a section of a dual lumen portion of the
invention dual lumen tube showing wire reinforcement thereof.
FIG. 4 is section 32 of FIG. 2.
FIG. 5 is section 33 of FIG. 2.
FIG. 6 is section 31 of FIG. 2.
FIG. 7 is section 30 of FIG. 2.
FIG. 8 is section 29 of FIG. 2.
FIG. 9 is an enlarged, cutaway section of a distal end of the
invention dual lumen tube of the invention dual lumen tube of FIG.
2.
FIG. 10 is a left side view of the distal end of the invention dual
lumen tube of FIG. 2.
FIG. 11 is an enlarged, cutaway section of a proximal end of the
invention dual lumen tube of FIG. 2.
FIG. 12 is an enlarged, cutaway section of an alternate proximal
end of the invention dual lumen tube of FIG. 2.
FIG. 13 is the invention dual lumen tube of FIG. 2 shown placed for
left bronchus placement of the bronchial tube as in the lungs shown
in FIG. 1.
FIG. 13A is a side view of an end-adjustable stylus adapted to
direct precise placement of a bronchial tube at the distal end of
the invention dual lumen tube.
FIG. 14 is the invention dual lumen tube of FIG. 2 shown placed for
right bronchus placement of the bronchial tube as in the lungs
shown in FIG. 1.
FIG. 15 is cross section 31 of FIG. 2 showing a cross section of a
bronchoscope or other slender cylindrical element within one lumen,
leaving the adjacent lumen available for ventilation.
FIG. 16 is cross section 31 of FIG. 2 showing a cross section of a
bronchoscope or other slender cylindrical element within one lumen,
leaving the adjacent lumen available for ventilation.
FIGS. 17 and 18 are cross section 31 of FIG. 2 showing alternate
forms of a flexible wall separating the lumens.
FIG. 19 is the alternate proximal end of FIG. 12, where each
proximal terminal end of each lumen is connected with a separate
ventilation tube, where separate ventilation tubes are joined into
a single ventilation tube and each separate ventilation tube is
optionally circumferentially enclosed with a control or monitor
element.
FIG. 20 is one form of a control element for a separate ventilation
tube of FIG. 19, where a pivoting clamp is shown in an open
position.
FIG. 21 is one form of a control element for a separate ventilation
tube of FIG. 19, where a pivoting clamp is shown in an closed
position.
FIG. 22 is a broken away view of the bronchial tube within the left
bronchus as in FIG. 13, angled to illustrate cuff and organ wall
contact.
FIG. 23 is the view of FIG. 22 with an alternate tracheal and
bronchial cuff.
FIG. 24 is the view of FIG. 22 with an alternate bronchial
cuff.
FIG. 25 is the view of FIG. 22 with an alternate bronchial
cuff.
FIG. 26 is the view of FIG. 22 with an alternate bronchial
cuff.
DETAILED DESCRIPTION OF THE INVENTION
The invention is now discussed with reference to the figures.
FIG. 1 is a front, cross section view of a human lung, shown the
tracheal and bronchial structures relevant to the present
invention. Especially relevant are the relative locations of the
main bronchi to the trachea.
FIG. 2 is a front view of one form of the invention dual lumen tube
10, having a proximal tube section 11 and a distal tube section,
which are continuous and joined to each other but are shown with an
indeterminate length break appropriate to an overall length of tube
10. For example an overall length of tube 10 for an adult will
typically be about 40 centimeters. Overall length of tube 10 is
reduced appropriately for pediatric and small adult sizes. It is
critical to the objects of this invention that the outside diameter
of sections 11 and 12 be less than or equal to approximately 13
millimeters for a large adult size and less than or equal to
approximately 12 millimeters or less for a small adult size. It is
a further critical feature of this invention to provide an outside
wire-reinforced wall thickness for sections 11 and 12 at less than
or equal to approximately 2.5 millimeters, and preferably less than
or equal to approximately 1.5 millimeters, where a flexible wall
separating two internal lumens has a wall thickness of less than or
equal to approximately 2.5 millimeters, preferably less than or
equal to approximately 1.5 millimeters, and most preferably from
approximately 0.5 to 1.5 millimeters. It is further preferred that
hydraulic cross section areas of two internal lumens in sections 11
and 12 are about equal before insertion of any solid device into
either lumen. These restrictions on dimensions establish hydraulic
cross sections within both lumens of sections 11 and 12 which are
adapted to accomplish the objects of the invention, i.e. that full
and required ventilation and respiration for a patient can be
achieved by ventilation of one lung while the other lung is
isolated for examination or treatment as described herein. The
present inventors have thereby minimized outside wall thickness by
helical wire reinforcement 34, as shown in FIG. 3, engaged to the
polymer of the outside wall, which extends internally from sealing
lines 38 and 39 to form lumen divider wall 35 between lumens 13 and
14. Referring again to FIG. 2, it is preferred that wire
reinforcement shown in FIG. 3 extend the lengths of sections 11 and
12, from point 36 to point 37.
FIG. 2 shows that section 11 extends up to transition piece 18,
wherethrough one lumen is extended up to single conduit 15 and 15
mm universal ventilator connector 19 and where the other lumen is
extended sideways to single conduit 16 and 15 mm ventilator
connector 20. Connectors 19 and 20 are adapted to either receive a
ventilator connection or to receive an insertable object, such as a
bronchoscope, a vacuum tube or a positioning stylet. FIG. 6 shows
additional detail of a cross section of section 11 (which is
identical with most of the length of section 12), where wall 35 is
formed so that it is convex to lumen 14 and concave to lumen 13.
Sealing lines 38 and 39 are located to the left of a cylindrical
center line. Cuff inflation tubes 21' and 22' correspond to,
referring again to FIG. 2, cuff inflation valves and tubing ends 21
and 22, where, respectively, those ends 21 and 22 are operated to
inflate or deflate tracheal cuff 23 and bronchial cuff 27. As such,
inflated cuff 23 is shown in FIG. 7 as section 30 of FIG. 2, where
an outside layer 40 is sealed to an inside layer 41, forming a
maximum outside diameter of about 30 millimeters for an adult
trachea and inflated cuff 27 is shown in FIG. 8 as section 27 of
FIG. 2, where an outside layer 42 is sealed to an inside layer 43,
forming a maximum outside diameter of about 22 millimeters for an
adult bronchus.
Referring to both FIGS. 2 and 9 for a description of a distal end
of tube 10, section 12 terminates at point 37, with lumen 13 having
a distal opening 24, which comprises a horizontal part 44 and an
angled, concave part 45. It is another important feature of the
invention that the combination of airflow parts 44 and 45 allow for
ventilation of a lung even if substantial portions of opening 24
are occluded by tissue or fluid. Angled bronchial extension 26
shall be formed to have an axis in its lumen extension space 14'
about 20-40 degrees from an axis of section 12, so that it is more
easily located in a desired bronchus at insertion. FIG. 10 provides
a clearer view of the part 45. A transition section 25 between
section 12 and a straight part of bronchial tube 26 may be formed
separately from section 12 and bonded and sealed to an appropriate
lumen opening of section 12 to achieve a desired angle
orientation.
FIG. 11 is an enlarged, cutaway section of portion of a proximal
end of the invention dual lumen tube of FIG. 2, where lumen 13
extends upward to lumen extension 49 defined by the inside walls of
single conduit 15. Transition piece 17 comprises a circumferential
band wall 46 defining circular opening 47, the opening 47 having a
diameter of about 8 millimeters or more to accommodate insertion of
a bronchoscope, tubing or stylet. A similarly sized circular
opening 48 is formed in section 11 and is aligned with opening 47.
A sealing plug 57 seals an upper, terminal end of lumen 14 at
opening 58.
FIG. 12 is an enlarged, cutaway section of an alternate proximal
end of the invention dual lumen tube of FIG. 2, where a Y-section
51 comprises single conduits 52 and 53 respectively extending in
spaces 55 and 56 the spaces of lumens 13 and 14. Short flange 54
maintains a gas tight separation of spaces 55 and 56, as does wall
35 maintain a gas tight separation of lumens 13 and 14.
FIG. 13 is the invention dual lumen tube of FIG. 2 is shown placed
for left bronchus placement of the bronchial tube 26 as in the
lungs shown in FIG. 1, where interface I-1 defines an interface
between sealingly inflated cuff 23 and the tracheal walls and
interface I-2 defines an interface between sealingly inflated cuff
27 and the left bronchus. FIG. 13A shows an end-adjustable stylet
81 comprising a slender shaft 82 terminating in an adjustable end
84, which is adjustable toward the right in the drawing by
depressing a button on handle 83. The stylet 81 is capable of being
inserted into single conduit 16 and then through lumen 14 to engage
bronchial tube 26 for placement into a bronchus as shown in FIG.
13.
FIG. 14 is the invention dual lumen tube of FIG. 2 shown placed for
right bronchus placement of the bronchial tube 26 as in the lungs
shown in FIG. 1, where interface I-1 defines an interface between
sealingly inflated cuff 23 and the tracheal walls and interface I-2
defines an interface between sealingly inflated cuff 27 and the
right bronchus.
FIG. 15 is cross section 31 of FIG. 2 showing a cross section of a
bronchoscope or other slender cylindrical element 60 within one
lumen 14, leaving the adjacent lumen 13 available for
ventilation.
FIG. 16 is cross section 31 of FIG. 2 showing a cross section of a
bronchoscope or other slender cylindrical element 60 within one
lumen 13, leaving the adjacent lumen 14 available for
ventilation.
FIGS. 17 and 18 are cross section 31 of FIG. 2 showing alternate
accordion forms 35' and 35'' of a flexible wall separating the
lumens.
FIG. 19 is the alternate proximal end of FIG. 12, where connectors
19 and 20 are respectively connected to separate ventilation tubes
63 and 64 at connectors 61 and 62. Tubes 63 and 64 extend to join
at junction 67. Along the lengths of tubes 63 and 64 are optionally
positioned one or more of circumferentially encasing a control or
monitor elements 65 or 66. Elements 65 or 66 may be electrical or
pneumatic measurement sensors whose output can be recorded to an
electrical recording device for pressure and volume of ventilation
to each of tubes 63 and 64. Elements 65 or 66 may also be flow
controllers as in FIG. 20 is one form of a control element 65 for a
separate ventilation tube 63, where a pivoting clamp 65 is shown in
an open position. Clamp 65 is a well known tube clamping device
that comprises a frame 69 with a horizontal plate connecting two
vertical plates 70 and 72, each defining an opening for tube 63
therethrough. An occluding bar 74 is fixed by living hinge to a top
end of plate 72, so that it rotates downward to a closed position,
as shown in FIG. 21, where tube 63 is shut tight with a free end of
bar 74 engaged to lateral extensions of plate 70. Additional
lateral extensions are available on plate 70 to provide for partial
closing of tube 63.
The assembly of FIG. 19 allows for independently variable
ventilation of each lung in combination with the tube 10 of FIG.
2.
FIG. 22 is a broken away view of the bronchial tube within the left
bronchus as in FIG. 13, angled to illustrate cuff and organ wall
contact.
FIG. 23 is the view of FIG. 22 with an alternate tracheal cuff 80
with a roughened, textured or undulating surface for improved
engagement to the tracheal wall. Bronchial cuff 76 is shown with a
proximal end flattened and a distal end angled to improve
engagement to the tracheal wall.
FIG. 24 is the view of FIG. 22 with an alternate bronchial cuff 77
is shown with a proximal end angled and a distal end angled in the
same direction to improve engagement to the tracheal wall.
FIG. 25 is the view of FIG. 22 with an alternate bronchial cuff 78
is shown with a proximal end flattened and a distal end angled to
improve engagement to the tracheal wall.
FIG. 26 is the view of FIG. 22 with an alternate bronchial cuff 79
is shown with a wall contact surface adapted so that a distal part
of set of adjacent engaging rings have a different surface angle
relative to tube 26 than a distal part, imparting an easier
insertion than withdrawal when in contact with the bronchus.
In a further form of invention reinforcement of the sections 11 and
12 of FIG. 2, helical reinforcement may be by way of extrusion
molding of a flexible polymer such as PVC, silicone or a polymer of
similar specifications in combination with a narrow gauge stainless
steel or metal wire or a rigid polymer ribbing (well known for
plastic reinforced hose and tubing, such as integral PVC ribbing)
with helical spacing of from 1 millimeter to 10 millimeters.
Alternately, but less preferably, sections 11 and 12 of FIG. 2 may
be reinforced with a mesh or web of polyester yarn or graphite
fibers to further reduce outside wall thickness. Still alternately,
the helical reinforcing may be replaced with spaced apart ribs or
rings of the same materials as stated for helical
reinforcement.
The above design options will sometimes present the skilled
designer with considerable and wide ranges from which to choose
appropriate apparatus and method modifications for the above
examples. However, the objects of the present invention will still
be obtained by that skilled designer applying such design options
in an appropriate manner.
* * * * *